NEW PRODUCTS / PRODUCT NEWS


Intermittent, Sequential Compression Therapy

The new VascuTherm 3 by ThermoTek offers a combination of treatment modalities that include intermittent pneumatic compression for edema reduction, thermal therapy (both cold and heat with alternating contrast) for pain management, compression for deep vein thrombosis prophylaxis, and a special modality to enhance arterial blood flow to treat arterial insufficiency. The VascuTherm 3 delivers a proprietary thermal compression therapy solution in one easily transportable device. Its solid-state technology eliminates the need for ice and offers precise temperature control combined with vascular compression.

VascuTherm 3 Arterial Enhancement therapy unit is used in conjunction with specially designed therapy wraps to transfer pressure to the foot and then the calf using compressed air, to increase arterial blood flow to the lower extremities. It is designed to enhance blood flow by providing targeted sequential compression of the foot followed by the calf using a rapid inflation/deflation pressure pulse. The compression cycle initiates with a quick compression of the popliteal space of the foot to 120 mm Hg within 1 second, then a sequential compression of the calf to 120 mm Hg within 2 seconds. Following the compression phase, the wraps are deflated rapidly and held at rest for a period of 16 seconds. The cycle is repeated 3 times per minute.

To learn more, contact

ThermoTek, Inc.
1200 Lakeside Parkway Ste 200
Flower Mound, TX 75028
www.thermotekusa.com


Preoperative Navigation

Wright Medical Group, Inc. has announced the full launch of its new PROPHECY™ Pre-Operative Navigation Guides for knee arthroplasty.

The PROPHECY program enables surgeons to utilize basic computed tomography or magnetic resonance imaging scan technology to plan precise implant placement and alignment, before they enter the operating room. Wright Medical notes that, in contrast to utilizing traditional instruments to align the knee during surgery, the PROPHECY program utilizes computer imaging to develop patient-specific guides that follow the unique curvature of the patient’s bone anatomy. The guides produced by the PROPHECY program should fit snugly onto the end of bone by matching the individual’s distinctive contour.

Once the procedure begins, patient-specific PROPHECY navigation guides allow the surgeon to complete the implant placement with accuracy. By promoting accurate alignment, providing optimal sizing, and guiding precision implant placement, Wright’s new PROPHECY preoperative navigation delivers reproducible surgical results for knee arthroplasty.

The PROPHECY™ Pre-Operative Navigation Guides are available in 2 options: an Alignment and Resection Guide and a Pin Alignment Guide.

For more information, contact

Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002
phone 901-867-9971
fax 901-867-9534
www.wmt.com


Innovative Knotless Suture Anchor System

Core Essence Orthopaedics, Inc., a medical device company focused on soft-tissue and skeletal repair of the extremities, announced it has received 510(k) regulatory approval from the Food and Drug Administration for SECURUS™, a novel knotless suture anchor system used in minimally invasive, arthroscopic surgery. The company notes that SECURUS provides increased flexibility, simplicity, and ease for surgeons seeking to employ minimally invasive techniques in the surgical treatment of rotator cuff repair. The 510(k) regulatory approval means Core Essence will be on track to ramp up distribution over the course of 2009.

SECURUS™ is an innovative implantable platform system that locks down sutures in arthroscopic tendon repair surgeries, particularly high-volume shoulder procedures focusing on rotator cuff repair. The product is available in 5.5-mm and 7.0-mm diameters to address varying degrees of bone quality, as well as rescue potential. The company notes that the SECURUS™ system also presents a number of distinct benefits, including: consistent, reproducible bone and suture retention strength, tactile tensioning of sutures (allowing the surgeon to “feel” the tension in the soft tissue prior to locking the anchor), and a readily revisable implant system. Unlike some knotless anchors, SECURUS™ can be adjusted intraoperatively and even removed and replaced.

For more information, contact

Core Essence Orthopaedics, Inc.
301 Oxford Valley Rd., Suite 905B
Yardley, PA 19067-7702
phone (215) 310-9534
fax (215) 660-5014
www.ceortho.com


Intramedullary Fixation System

NovaLign™ Orthopaedics, Inc., received its first 510(k) clearance from the US Food and Drug Administration to market its Intramedullary Fixation System, a new system of implants and instruments for the treatment of long bone fractures, including the humerus, tibia, and femur.

Extensive preclinical testing in accordance with internationally recognized testing standards and applicable FDA guidances support NovaLign’s 510(k) clearance. The company plans to initiate clinical studies in Europe and the United States later this year.

In contrast to surgical approaches in which intramedullary nails are inserted through the nearest joint, the NovaLign extracapsular intramedullary device is designed to allow a surgeon to repair a long bone fracture without violating the nearby joint space, instead entering the medullary canal from outside of the joint. NovaLign’s goal is to avoid damage to the surrounding tissue, thereby minimizing the complications that may be experienced with traditional surgical techniques.

For more information, contact

NovaLign™ Orthopaedics, Inc.
5885 Ridgeway Center Parkway, Suite 210
Memphis, TN 38120
phone 901-213-5151
www.novalign.com


Spinal Bone Injury Treatment

Osseon Therapeutics, Inc., announced the commercial release of their Osseoflex™ and Osseoperm™ systems for the treatment of spinal bone injuries. These products combine to form a new procedure termed Osseoplasty™, which allows for a minimally invasive treatment of painful compression fractures of the spine, seen increasingly in older individuals with osteoporosis. Thousands more develop compression fractures as a result of trauma or malignant disease such as breast cancer, prostate cancer, and myeloma.

Osseoflex is a steerable and curvable needle that can access the majority of the vertebral body from a single percutaneous access point. The company notes that the Osseoperm system is customized to deliver optimal cement viscosity and precise cement placement through the Osseoflex needle.  Osseon notes that, as a result, the Osseoplasty procedure provides rapid stabilization of vertebral fractures and significant pain relief in most patients within the same day. It plans to market its Osseoplasty system throughout the United States.

To learn more, contact

Osseon™ Therapeutics, Inc.
2330 Circadian Way
Santa Rosa, CA 95407
phone (707) 636-5940
fax (707) 636-5941
www.osseon.com